Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision (SORKYSA)

University Hospital, Strasbourg, France

Status: Completed

Conditions: Sinus Pilonidal

Treatments: Device: Algosteril TM; Device: Sorbact TM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02011802

5568

Details and patient eligibility

About

Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).

The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man or woman over 18 years old

• Informed consent signed by the participant

• Affiliation to social security system

• Having a pilonidal sinus:

  • Asymptomatic or discovered by the patient during a routine examination
  • With chronic recurrent infection and skin rupture

Exclusion criteria

• Patients with concomitant pathology:

  • cancer treated by chemotherapy
  • Hypertension uncontrolled systolic blood pressure>180 mmHg or diastolic> 110 mmHg
  • Severe comorbidity with reduced life expectancy less than 12 months
  • Acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion

• Patients participating in another clinical trial

• Known for intolerance to one of the dressings

• Known pregnancy

• Uncontrolled diabetes (fasting glucose >2g/l)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Algosteril TM

Active Comparator group

Description:

Calcium alginate dressings are made from seaweed. Calcium alginate dressings form a natural gel of the exudates against the healing tissue that keeps it moist and supple, aiding in healing and tissue growth. In addition, this gel material forms a natural barrier to bacteria that may complicate healing with secondary infections of the wound. Alginates are the reference of dressing after sinus pilonidal excision.

Treatment:

Device: Algosteril TM

Sorbact TM

Experimental group

Description:

DACC (dialkylcarbamoyle chloride) is a main component of the bacterial binding wound dressing: Sorbact. DACC is a hydrophobic fatty acid derivative that can be used to coat dressing materials, resulting in a dressing with highly hydrophobic pathogen binding properties. This is a primary wound interface dressing and is effective when in close contact with the wound bed in a moist environment.

Treatment:

Device: Sorbact TM